The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.

“Single drugs targeting single biological pathways are insufficient for complex diseases,” Remedy Cell Ltd. CEO Ayelet Dilion Mashiah told BioWorld. Remedy is taking a secretome-based approach to treat lung disorders, having moved its lead asset, RC-0315, into a first-in-human clinical trial for idiopathic pulmonary fibrosis (IPF) in January.

Addex Therapeutics Ltd. has announced findings from the evaluation of its γ-aminobutyric acid subtype B receptor (GABA[B]) positive allosteric modulator (PAM) in a nonhuman primate (NHP) model of chronic cough. In the study, the GABA(B) PAM drug candidate significantly reduced citric acid-induced cough frequency.

The ability of Ebenbuild GmbH’s digital twin technology to predict the deposition of inhaled drugs across the lungs has been validated in a study published in Nature Communications Medicine. The platform, which combines AI-driven image analysis and physics-based computational modeling, demonstrated strong agreement with in vivo imaging data across multiple inhalation scenarios.

The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.

Acute lung injury (ALI) is a severe inflammatory condition marked by disruption of the alveolar-capillary barrier and impaired gas exchange. Emerging evidence implicates cathepsin L as a key contributor to ALI pathogenesis through protease-mediated tissue damage and amplification of inflammatory responses. Researchers from Zhejiang University of Technology reported the development of a new cathepsin L inhibitor designed for the treatment of ALI.

“Single drugs targeting single biological pathways are insufficient for complex diseases,” Remedy Cell Ltd. CEO Ayelet Dilion Mashiah told BioWorld. Remedy is taking a secretome-based approach to treat lung disorders, having moved its lead asset, RC-0315, into a first-in-human clinical trial for idiopathic pulmonary fibrosis (IPF) in January. Secretomes refer to the collection of bioactive molecules secreted by cells in the extracellular space, including proteins, enzymes, growth factors and extracellular vesicles such as exosomes.

Copper overload within the body may lead to cancer, neurodegenerative diseases, inflammation or fibrosis, among others. Copper chelation is an effective strategy to counteract this potential overload; mitochondria play an important role, as they are the main copper-using organelles in the cells. Copper chelators have been developed, but they have shown some undesired off-target effects and low specificity, which suggests the need for new therapies in the field.

United Therapeutics Corp. is eyeing a possible priority review in its anticipated supplemental NDA for Tyvaso (treprostinil) in idiopathic pulmonary fibrosis (IPF) after the second phase III trial hit its endpoints, even besting the impressive findings from the first phase III study reported last year, and positioning United for a substantial commercial launch in 2027.